Various devices have been proposed in past years for directing and collecting urine from female patients suffering from urinary incontinence but, in general, such devices have been associated with problems of leakage, wearer discomfort, pressure sores, and even necrosis. An indication of the ineffectiveness of such prior devices lies in their lack of commercial success.
The problems associated with prior devices are particularly pronounced with ambulatory patients because of the varied and complex anatomical changes that occur in the periurethral area during locomotion and the failure of such devices to coapt to such changes. However, the need for an effective device is by no means limited to ambulatory patients. For example, non-ambulatory female patients with spinal cord injuries are not served well by existing devices (indwelling catheters, intermittent catheters, diapers, etc.) despite only minimal body movement of such patients.
Prior patents have disclosed female urinary collection devices equipped with locating elements intended to be inserted into the vagina for retaining the collection devices in operative positions. Reference may be had to U.S. Pat. Nos. 2,483,079, 2,490,969, 3,116,734, 3,528,423, 3,512,185, 3,776,235, 3,661,155, and 4,246,901. Those constructions in which the locating elements are relatively rigid clearly fail to conform with the anatomical changes occurring during body movement. While prior devices with flexible or deformable vaginal locating elements may reduce tissue irritation and increase patient comfort, problems in providing an effective seal and avoiding leakage along the lines or zones of contact have nevertheless remained.
Other patents of interest are U.S. Pat. Nos. 4,270,539, 3,651,810, 4,198,979, and 3,194,238.